Impact of Aerobic Exercise on Asthma Morbidity (Ex-Asthma)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Hopital du Sacre-Coeur de Montreal
Sponsor:
Collaborators:
McGill University Health Center
Jewish General Hospital
Information provided by (Responsible Party):
Simon Bacon, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
NCT00953342
First received: August 4, 2009
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

Asthma is a chronic disorder of the airways primarily driven by increased airway inflammation, and is an escalating medical problem in Canada. For example, between 1994 and 2001 there was a 40% increase in the number of Canadians who had asthma. Not only is the prevalence of asthma increasing but there has been a rapid rise in the number of asthma events and costs associated with asthma and poor asthma control. It has been estimated that the global cost of caring for asthma exceeds that of AIDS/HIV and tuberculosis combined. These increases have occurred in spite of the development of clear asthma management guidelines. There is evidence to suggest that aerobic exercise, e.g., running or cycling, may improve asthma symptoms and control in children. However, there are currently no studies that have systematically assessed the effects of exercise on asthma control or symptoms in adults. The current proposed study will assess the effects of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual medical care, 52 patients will participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain usual medical care. The asthma control, quality of life, and inflammatory profile will be evaluated at baseline and following the 12 weeks of treatment. The investigators believe that: (1) The exercise intervention will significant improve asthma control and asthma quality of life; (2) The exercise intervention will result in significant improvements in inflammatory profiles; and (3) These changes in the inflammatory profile will be directly related to the improvements in asthma control and quality of life.


Condition Intervention Phase
Asthma
Behavioral: Aerobic exercise
Behavioral: Usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Aerobic Exercise on Asthma Morbidity

Resource links provided by NLM:


Further study details as provided by Hopital du Sacre-Coeur de Montreal:

Primary Outcome Measures:
  • Asthma control Questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma quality of life questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]
  • Asthma control test [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic exercise
12 weeks of supervised aerobic exercise and standard care
Behavioral: Aerobic exercise
12 weeks of supervised exercise, 3 x week, 1 hour sessions
Placebo Comparator: Usual care
12 weeks of standard care
Behavioral: Usual care
Standard medical care

  Hide Detailed Description

Detailed Description:

Introduction: Asthma is a chronic respiratory disorder primarily driven by increased airway inflammation. It is one of the most prevalent chronic conditions affecting Canadians. It is the most common chronic illness affecting children and the fourth most common disorders affecting adults. In 2001, nearly 2.2 million (8.4%) Canadians were diagnosed as having asthma. More importantly, asthma is an escalating medical problem in Canada, e.g., between 1994 and 2001, there was a 40% increase in the number of Canadians with asthma. Not only is the prevalence of asthma increasing, but there has been a rapid rise in the morbidity and costs associated with asthma and its poor control. The WHO estimated that the global cost of caring for asthma exceeds that of AIDS/HIV and tuberculosis combined. Though recent guidelines have emphasized the importance of improving asthma control and quality of life, leading to huge amounts of resource being dedicated to this, more than 50% of adult patients with asthma remain poorly controlled. As current treatment strategies appear to be failing, it is important to target simple, cost effective interventions that are applicable for most patients with asthma and will increase overall levels of control and decrease asthma morbidity. There is evidence to suggest that aerobic exercise may improve asthma symptoms and control in children. In addition, there is evidence that exercise directly improves inflammatory and immune profiles in non-asthma patients, which may provide the mechanism by which exercise could improve asthma. However, there are no known studies that have systematically assessed the effects of aerobic exercise on asthma control, quality of life or immune function in adult asthma populations.

Objective: The primary objective of the current application is to assess the efficacy of aerobic exercise as an intervention to improve asthma control and quality of life in adult patients with asthma. The results of this study will provide data that will inform physicians and members of the Thoracic community about the benefits of exercise for asthma. The study will also assess potential inflammatory pathways by which exercise may elicit improvements in asthma morbidity. The results of this study should be available for the next Canadian Thoracic Society Canadian Adult Consensus Guidelines.

Methodology: The current proposal is for a study of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual care, 52 patients will undertake supervised aerobic exercise. The exercise program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. The exercise routine, under medical supervision, will consist of 10 minutes of warm up exercises, 40 minutes of biking and/or walking (and eventually jogging), and 10 minutes of cool down exercises. These patients will be compared to a group of 52 patients who will follow their usual regimen, this group will be offered the exercise programme once they have completed the post assessments. For the primary outcomes (asthma control [Asthma Control Questionnaire], quality of life [Asthma Quality of Life Questionnaire]) and secondary outcomes (inflammatory profile) will be evaluated at baseline and after 12 weeks (the length of the treatment). To check the efficacy of the intervention both lung function, ambulatory peak flow, and exercise tolerance data will also be collected. Repeated measures analysis of covariance-type models with time (pre, post intervention) as the within subject factor, group (exercise, usual care) as the between factor, and sex, age, and asthma severity as the covariates will be used for the primary outcome variables. To assess the potential mechanistic role of inflammation on the exercise-asthma relationship a series of regression-like GLMs will be conducted.

It is hypothesized that: (1) The exercise intervention will result in clinically and statistically significant improvements in levels of asthma control and asthma quality of life; (2) The exercise intervention will result in clinically and statistically significant improvements in inflammatory profiles, with reductions in Th2 cytokines, and activation of inflammatory cells, and increases in Th1 cytokines; and (3) Changes in inflammatory profile will be directly linked to improvements in asthma measures.

We believe that the proposal will have great clinical significance for patient management. This project will be the first to systematically evaluate the benefits of exercise training on asthma control and quality of life in adult asthma patients. We anticipate that the results of this study will form the basis for new national and international guidelines and will provide an evidence-based background for physicians to prescribe aerobic exercise for patients with asthma.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician diagnosed asthma (confirmed by medical record evidence of bronchodilator reversibility of 12% or a minimum of 180 cc or PC20 methacholine <= 16 mg/ml)
  • Sedentary (currently do less than 60 min of structured / planned physical activity per week)
  • Taking at least 250 mg fluticasone equivalent per day
  • On stable dose and regimen of asthma medications
  • Mild to moderate symptomatic asthma as defined by an Asthma Control Questionnaire score of 1.25 or greater.

Exclusion Criteria:

  • Diagnosed co-morbid disease for which there are already established exercise guidelines i.e., cardiac disease or COPD
  • Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer) which will confirmed by physician review
  • FEV1 lower than 60% of predicted
  • Incapable of exercising
  • A BMI > 30 kg/m2
  • Unable to speak or understand either French or English
  • <18 years of age
  • Patients who are currently pregnant or intend to become pregnant over the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953342

Contacts
Contact: Guillaume Lacoste, BSc 514-338-2222 ext 3364 g_lacoste_@hotmail.com
Contact: Chantal Daigneault, BSc 514-338-2222 ext 3364 chantal.daigneault@crhsc.rtss.qc.ca

Locations
Canada, Quebec
Hopital du Sacre-Coeur de Montreal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Principal Investigator: Simon L Bacon, PhD         
Sub-Investigator: Kim L Lavoie, PhD         
Sub-Investigator: Manon Labrecque, MD         
Sub-Investigator: Karim Maghni, PhD         
Sub-Investigator: Veronique Pepin, PhD         
Sub-Investigator: Denyse Gautrin, PhD         
Montreal Chest Institute Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact: Katrina Metz, BSc    514 934 1934    katrina.metz@mail.mcgill.ca   
Principal Investigator: Jean Bourbeau, MD         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Guillaume Lacoste, BSc    514 338 2222 ext 3364    g_lacoste_@hotmail.com   
Principal Investigator: Pierre Ernest, MD         
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
McGill University Health Center
Jewish General Hospital
Investigators
Principal Investigator: Simon L Bacon, PhD Hopital du Sacre-Coeur de Montreal / Concordia University
  More Information

Additional Information:
No publications provided

Responsible Party: Simon Bacon, Researcher, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT00953342     History of Changes
Other Study ID Numbers: MOP93807
Study First Received: August 4, 2009
Last Updated: October 16, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Hopital du Sacre-Coeur de Montreal:
AEROBIC EXERCISE
ASTHMA CONTROL
ASTHMA QUALITY OF LIFE
INFLAMMATION
TREATMENT

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014